Determining the effectiveness of cognitive behavioral therapy on dysfunctional thoughts and self-differentiation with symptoms of anxiety disorders in adolescents
Design
A controlled clinical trial with parallel groups, single-blind, randomized, on 30 adolescents. The rand function of Excel software was used for randomization.
Settings and conduct
Method: The study will be conducted as a quasi-experimental study with pre-test-post-test and control group, with convenient sampling and random allocation in accredited counseling centers in Ahvaz.
Location: Licensed counseling centers and psychological clinics in Ahvaz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adolescents aged 12-18 years with a diagnosis of anxiety disorder (DSM-5), informed consent, and no active medication. Exclusion criteria: Severe psychiatric disorders, intellectual disability, or concurrent participation in other research.
Intervention groups
Intervention group: Received 12 structured cognitive-behavioral therapy (CBT) sessions (weekly, 60 minutes) focusing on identifying and modifying dysfunctional thoughts and improving self-differentiation.
Control group: Received a non-specific intervention (such as general psychoeducation about anxiety, without active CBT techniques) or a waiting list (if no alternative intervention was available).
The effectiveness of cognitive behavioral therapy on dysfunctional thoughts and self-differentiation with symptoms of anxiety disorders in adolescents
Public title
The effectiveness of cognitive behavioral therapy on dysfunctional thoughts and self-differentiation with symptoms of anxiety disorders in adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 12 to 18 years
Diagnosis of anxiety disorder
Informed consent of the adolescent and parents.
Exclusion criteria:
Taking medications that affect anxiety
Receiving parallel psychological treatment
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization was performed using SPSS software. Participants were divided into blocks of 4 based on anxiety symptom severity (with GAD-7 questionnaire) and gender, then randomly assigned to intervention (CBT) and control (waiting list) groups. Allocation concealment was ensured with sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants and therapist are aware of the grouping, but because the assessors are unaware, this method of blinding is considered one-sided.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Ahvaz Branch
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Approval date
2025-04-05, 1404/01/16
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.008
Health conditions studied
1
Description of health condition studied
Anxiety disorders
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders
Primary outcomes
1
Description
Decreased anxiety symptom score
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
1
Description
Reducing dysfunctional thoughts
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Spontaneous Thoughts Questionnaire
2
Description
Improving self-differentiation
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Self-Differentiation Questionnaire
Intervention groups
1
Description
Intervention group: (Cognitive-behavioral therapy - CBT): Protocol: 12 weekly 60-minute sessions based on the American Psychological Association (APA) treatment guidelines. Content: Training in identifying negative thoughts, cognitive restructuring, gradual exposure, breathing and relaxation exercises, problem-solving skills.
Category
N/A
2
Description
Control group: Received usual services: unstructured supportive counseling (45 minutes per week) including active listening and general advice
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Unit
Full name of responsible person
Behnam Makvndi
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnam Makvndi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnam Makvndi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Anis Taghikhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 9, Complex, East 8th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Fax
Email
Anistaghikhani78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available